The present invention relates generally to a minimally invasive approach to adjust a flexible areal polymer implant for supporting an anatomical structure and further relates to an approach especially useful for use with implants that support the urethra for treating female urinary incontinence.
Women account for more than 11 million of incontinence cases.
Moreover, a majority of women with incontinence suffer from stress urinary incontinence (SUI). Women with SUI involuntarily lose urine during normal daily activities and movements, such as laughing, coughing, sneezing and regular exercise.
SUI may be caused by a functional defect of the tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Common causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. Such a defect results in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder.
Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle, shying away from social situations.
U.S. Pat. No. 5,112,344 describes a method and apparatus for treating female incontinence. The surgical instrument for the application of a filamentary element into the body comprises a tubular shaft having a handle at one end and a flexible needle slidably receivable in the shaft and adapted at one end to receive a filamentary element. The method of treating female incontinence comprises looping a filamentary element between the wall of the vagina and the rectus abdominis sheath in the anterior wall of the abdomen whereby it passes to each side of the urethra, adjusting the loop to bring the vaginal wall and the urethra into the correct spatial relationship to the pubis allowing the development of scar tissue between the vaginal wall and the anterior wall of the abdomen pubic symphysis and removing the filamentary element.
U.S. Pat. No. 5,899,909 discloses a surgical instrument comprising a shank having a handle at one end and connecting means at the other end to receive, one at a time, two curved needle-like elements which are connected at one end to one end of a tape intended to be implanted into the body. In practice, the tape is passed into the body via the vagina first at one end and then at the other end at one side and the other, respectively, of the urethra to form a loop around the urethra, located between the urethra and vaginal wall. The tape is extended over the pubis and through the abdominal wall and is tightened. The tape ends are cut at the abdominal wall, and the tape is left implanted in the body. U.S. Pat. No. 5,899,909 is incorporated herein by reference.
While implanting a tape, it is often difficult to determine the most suitable amount of support to provide to the urethral structure. An optimal amount of support is defined as that which provides relief from incontinence and simultaneously provides for normal micturition. Even if the most optimal amount of support is provided during implantation, it is possible that the surrounding tissues will change during the healing process or simply due to aging. As a result, the optimal amount of support is subject to change.
European Patent 0941 712 A1, José Gil-Vernet Vila, describes an approach to adjusting urethral support by use of an expandable container implanted remotely from the urethra and connected to a mesh supporting the urethra. While this provides adjustment capabilities, the associated surgical procedure is invasive and complex. The container is also complex and requires features to assure that the suspending threads are not abraided. The container is preferably located in adipose tissue in the abdominal region. The container's location exposes it to distortion whenever there are external forces applied to the abdominal area. This in turn is expected to transiently change the degree of support to the urethra whereas it is desirable to provide a fairly constant level of support. Since the mesh support is directly in contact with the urethra, the fluctuations of support to the urethra can become irritating to the surrounding tissue.
U.S. Pat. No. 6,042,534, Gellman et al., describes the use of a visual indicator that may be radiopaque. However, there is no specific description of how to achieve this effect and makes no mention of its use with a tape support device. Further, the purpose of this indicator is solely for assessment of the relative position of the sling used to support the urethra. Gellman is silent with respect to the need to adjust the sling after it is in place.
U.S. Pat. No. 5,611,515, Theodore V. Benderev et al., describes the use of a suture tensioning devices in conjunction with bladder neck suspension. These tensioners are used to adjust the tension on sutures used to hold a supportive sling in place on the bladder neck. Prior to tying, sutures are appropriately tensioned by advancing the suture around a suture tensioner and tying in a conventional manner. Thereafter, the suture tensioner is removed and the surgical site prepared and closed in a conventional manner. While this technique is fine for establishing the initial tension to the sling, it does not allow for post implantation adjustment. Also, this approach is fine where the sling is suspended with sutures or other filament means. However, such tensioning devices are unsuitable for tapes implanted such as those associated with the GYNECARE TVT Tension-Free Support for Incontinence.
International Patent WO 98/31301 discloses an implantable continence device that consists of a hydraulic and mechanical component.
Therefore there is a need to be able to adjust the level of support to the urethra in a less complicated manner and with no urethra-mesh contact. Further, the adjustment should be located in close proximity to where the support is needed.
The present invention discloses devices and methods for adjusting the support of internal anatomical organs both during and after implantation. In particular, the invention is intended to be especially useful for use with implants that support the urethra.